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CalHHS DxF Implementation Advisory Group - Data Sharing Agreement PP Subcommittee Meeting - Shared screen with speaker view
Steven Lane
36:39
Agree with Mark Savage that push messaging between participants is a critical component of functional interoperability, especially as relates to care coordination. Ad hoc push, in particular, is valuable for care team members to coordinate care.
Deven McGraw, Invitae (she/her)
38:09
I have made a presumption that individual access will be taken care of in a separate policy - perhaps that’s true of adding other push use cases
Steven Lane
43:35
Most providers have the ability, through their certified EHR, to send a Direct secure message with appropriate attached documents, including a Continuity of Care Document, to other care team members with a Direct address available through the national directory. This is an inexpensive and readily available tool set to support the much needed coordination of care between medical and social/community service providers.
Deven McGraw, Invitae (she/her)
44:30
Yes, if both endpoints are Direct-capable. Users of certified systems likely have lots of options not available to those who do not.
Steven Lane
46:27
Yes, and plenty of Health Information Service Provider (HISP) vendors provide inexpensive access to Direct via web-based apps that could be utilized by those without already capable/enabled software systems.
Belinda Waltman
49:34
On slide 18, 1.a.ii. states that participant delivering the electronic HSSI must ensure participant is authorized to receive the data. We discussed this in the earlier DSA meetings, but this bullet implies consent-driven management and potential data tagging of data elements that require consent (Part 2 data, LPS, HIV test results in some cases, etc). Should language be added here to reference the "how" of consent-driven management?
Steven Lane
52:28
https://www.healthit.gov/sites/default/files/page/2020-07/0720_Direct%20Secure%20Messaging%20Basics.pdf
Steven Lane
54:50
That consent could be provided as part of providing consent for services and receiving the HIPAA Notice of Privacy Practices. If individuals need to opt in specifically to this exchange it will not scale.
Deven McGraw, Invitae (she/her)
55:14
I think the intent on securely destroy is just to make sure that the information that wasn’t supposed to be disclosed in the first place is disposed of in a way that doesn’t increase risk - maybe take care of in security P&Ps?
Deven McGraw, Invitae (she/her)
55:34
Fwiw, requiring secure destruction is consistent with the HIPAA security rule.
Steven Lane
56:12
👍
Diana Kaempfer-Tong
57:34
For awareness around consent and authorization Not all participants use HIPAA notices of privacy practices. Most of CDPH is not HIPAA covered.
Deven McGraw, Invitae (she/her)
58:40
Yes - but we reference HIPAA standards for all participants in other aspects of these policies, as I recall, in order to try to create more of a level playing field. But consistent with Shelley’s comments, if you need to get consent before you share data, it would be your obligation to do so as the sender per the framework agreement (or if your particular legal obligations don’t allow you to collect data without a patient’s authorization/consent).
Deven McGraw, Invitae (she/her)
01:01:54
I think it would be really helpful to map out a bunch of expected use cases, and the obligations on each end of those transactions.
Deven McGraw, Invitae (she/her)
01:02:16
For different types of Participants
Mark Savage
01:03:12
Agree that use cases with information flows would help tremendously to tweak the language in ways we've been discussing so far.
Steven Lane
01:04:54
The standard for https://directtrust.org/standards/event-notifications-via-directsending ADT notifications via Direct:
Steven Lane
01:05:23
Again, this is the standard for sending ADT notifications via Direct: https://directtrust.org/standards/event-notifications-via-direct
Belinda Waltman
01:05:25
Minor thought for this ADT section - even though this is the technical req P&P, should it reference the real-time P&P here to let readers know that there are also timing expectations?
Steven Lane
01:06:11
We should not assume that Event Notifications must go through a QHIO, unless that definition includes Direct as an appropriate method/HIO.
Deven McGraw, Invitae (she/her)
01:07:56
I think the QHIO provisions are intended to govern when QHIOs are utilized - I could see these, and other, provisions also part of the criteria for which HIOs are judged on whether they can be QHIOs. But if we are going to promote Direct in these policies, do we also need to include those standards or vet providers of those services if we’re going to recognize that methodology expressly in these policies.
Deven McGraw, Invitae (she/her)
01:08:46
Again, I do not think this policy requires use of a QHIO - just making sure that if a participant uses an HIO, they are using one that meets the requirements. Potentially we need similar requirements for other technologies we are encouraging people to use....
Jason Buckner
01:08:52
I believe that it should be A AND B are required, not one or the other.
Mark Savage
01:09:39
To Bill's question, wouldn't the requirement to use one or the other means that if a.i.a. does not work (if one wants that), then must use a.i.b.
Mark Savage
01:09:57
*mean
Jonah Frohlich
01:10:51
If a hospital is able to meet requirements to notify participants in accordance with required standards, why must it be required that they use a QHIO if they can fulfill the requests through other means (Direct or otherwise)?
John Helvey
01:12:10
Are the Hospitals required to notify the payers with ADT as well? They are players in this as well, not just providers.
Jason Buckner
01:13:10
The issue is with a provider who wants to receive notifications, but does not want to comply with the burden of a hospitals preferred method of delivering notifications, which often entails paying a 3rd party vendor.
William (Bill) Barcellona
01:13:40
It is unlikely that independent, small practices in larger networks like ACOs and IPAs will be able to accomplish direct exchange with hospitals. This has been a common problem. QHIOs are the most likely solution. But the goal of getting ADT information exchanged is a KEY priority for improving patient outcomes.
Jason Buckner
01:13:58
Having the hospital provide that ADT to a QHIO provides a digital safety net for those providers to receive that ADT notification from a QHIO.
John Helvey
01:14:13
How will all of this play in the Population Health Initiatives that are currently moving forward.
John Helvey
01:14:22
agree with Jason Buckner
Mark Savage
01:15:07
Agree about QHIO being a digital safety net for ADT notification!
Steven Lane
01:15:14
In this exchange purpose, do we have a plan to support limiting responses to the Minimum Necessary data required/requested?
Deven McGraw, Invitae (she/her)
01:15:59
Minimum necessary not required for treatment under HIPAA, fwiw. In general, we require senders to comply with applicable law in their responses, per Shelley’s earlier comment.
Steven Lane
01:16:04
Many times a Continuity of Care Document (CCD), the most common response to an IHE query, contains more information than necessary for some use cases.
John Helvey
01:16:56
With these mandates for both hospitals and QHIO's is there funding to support this comprehensive model of ADT communications and appropriate management thereof
Diana Kaempfer-Tong
01:17:03
Explanation on what would qualify as an “appropriate null response or error message” would increase clarity corresponding participants
Diana Kaempfer-Tong
01:17:33
*responding participants
Steven Lane
01:17:53
As community and social service providers will have access and ability to query, and we state that they must comply with HIPAA, does this imply that they need not request minimum necessary, or that data providers are excused from Min Necessary restrictions?
Deven McGraw, Invitae (she/her)
01:18:45
Do you consider a community and social service provider to be acting as “treatment” for the patient? If so, minimum necessary won’t apply under HIPAA.
Deven McGraw, Invitae (she/her)
01:19:05
(And care coordination, when done in the context of “treatment,” is considered treatment and not operations)
Steven Lane
01:20:00
https://www.healthit.gov/sites/default/files/page2/2020-08/Health_Care_Provider_Definitions_v3.pdf
Steven Lane
01:21:30
It seems that only certain community/social service providers meet the definition of “Provider” under applicable law. Is is acceptable to say that (categories of) individuals are providing Treatment if they are not a Provider?
Steven Lane
01:26:11
Project US@ is pronounced “Project USA”
Steven Lane
01:27:10
https://www.healthit.gov/isa/uscdi-data-class/patient-demographicsinformation#uscdi-v2
Deven McGraw, Invitae (she/her)
01:27:29
Maybe there is a requirement we should put in that requires those who query for data to ask for only what they need to meet the purpose, and the concomitant duty to respond is to provide the data requested, recognizing that in some cases it may be difficult from a technical standpoint to segment data not requested? And in push transactions, the obligation should be on the entity initiating the push to provide the data required in a way that is consistent with law.
Deven McGraw, Invitae (she/her)
01:27:56
(Correction - respondent is to provide the data requested consistent with law )
Steven Lane
01:28:26
Good approach, Deven. 👍🏼
Mark Savage
01:30:17
Here's HITAC's Interoperability Standards WG language: "Current and Previous Address should contain not only the components of address (number, street name, city, state, zip) in accordance with the Project US@ specification, but also must contain a value or values from the Patient Address Metadata Schema, which is able to represent homelessness or temporary addresses.”
Jason Buckner
01:30:26
Devon - so a requestor could ask for demographics, encounters, results and procedures. And the respondent should ONLY include those elements? Is that what you are proposing?
Steven Lane
01:32:58
Good to see that this review will be completed at least annually.
Deven McGraw, Invitae (she/her)
01:32:59
Jason, where technically feasible, yes. But where those elements requested are part of document that has other elements in it, like a CCD, and it’s not possible to carve those out, then the CCD could be sent in order to meet the needs of the requestor. Just trying to think about how to address Steven’s concerns about minimum necessary, including in the context of social services where it’s not clear they would be exempt from minimum necessary under hIPAA’s treatment exemption. Trying to balance fair information practices with practical realities of document-centered exchange architectures.
Jason Buckner
01:34:31
Got it and it makes a lot of sense when considering technical feasibility.
Steven Lane
01:34:45
I anticipate that many providers will be reluctant to send a full CCD to community care organizations that are not clearly HIPAA covered entities even if we say, as part of the State DxF, that those individuals are bound by HIPAA.
John Helvey
01:36:54
I agree with Steven...we need to align communications and common language with the Feds...Otherwise it is going to complicate and confuse. It is already confusing enough
John Helvey
01:38:17
second Jason and Mark on no need to change the name
John Helvey
01:39:00
thank you
Diana Kaempfer-Tong
01:39:50
Referring to it as the California Information Blocking Rule would be clearer for those participants only subject to the rule through this policy
Mark Savage
01:42:53
And the Early Exchange P&P states that these effective dates don't apply to early exchange.
Steven Lane
01:43:05
Under the federal rules it is HHS OCR that determines whether an action constitutes Information Blocking. 
https://inquiry.healthit.gov/support/plugins/servlet/desk/portal/6
Deven McGraw, Invitae (she/her)
01:44:10
No, actually it’s OIG (Office of the Inspector General). For state policy violations, there will need to be an enforcement body/entity to decide whether blocking has occurred.
Steven Lane
01:44:32
Thanks!
Steven Lane
01:45:32
Do we anticipate a parallel State process for adjudicating InfoBlocking complaints?
Steven Lane
01:46:22
If so, could this, perhaps, apply only to actors in CA not covered by the federal InfoBlocking prohibitions?
Steven Lane
01:49:25
https://www.healthit.gov/sites/default/files/page2/2020-03/InformationBlockingExceptions.pdf
Deven McGraw, Invitae (she/her)
01:57:31
Do we really want a health care provider being able to charge a fee to a social services agency for sending them data? The could if they rely on the info blocking fee exception in terms of the scope of that fee
Steven Lane
01:59:35
Perhaps we could specifically prohibit that, Deven.
Steven Lane
02:00:58
This does seem a reasonable approach to expanding the scope of this authority.
Deven McGraw, Invitae (she/her)
02:01:37
That’s what I was talking about in terms of making sure the fee and licensing exceptions wouldn’t apply to that type of exchange, while making sure that entities/organizations providing the “interoperability elements” (mechanisms for exchange) could operate consistent with the federal fee and licensing exceptions.
Steven Lane
02:02:21
Helpful FAQ: https://www.healthit.gov/sites/default/files/page2/2020-03/InformationBlockingExceptions.pdf
Steven Lane
02:03:09
The FAQ above provides detail regarding Type of Harm and how this applies, under InfoBlocking and HIPAA, based on the requestor.
Diana Kaempfer-Tong
02:13:10
Change to applicable law is appreciated.
Deven McGraw, Invitae (she/her)
02:22:04
Apologies. Am going to log back on, as I am experiencing some technical difficulties.
Jonah Frohlich
02:22:29
"California Information Blocking Prohibitions"?
Steven Lane
02:22:36
👍🏼
John Helvey
02:22:36
good with California Information Blocking P&P
Jonah Frohlich
02:23:31
Good suggestion Diana and Steven, thank you!
Steven Lane
02:25:57
It may be helpful to refer to the timeliness of making data available as opposed to the timeliness of exchange, as delays in the exchange itself may not be under the control of the data holder.
Steven Lane
02:29:18
ONC InfoBlocking FAQ: When would a delay in fulfilling a request for access, exchange, or use of EHI be considered an interference under the information blocking regulation? https://www.healthit.gov/faq/when-would-delay-fulfilling-request-access-exchange-or-use-ehi-be-considered-interference-under
Jason Buckner
02:32:45
I second that comment by John Helvey
Steven Lane
02:33:21
I am also concerned that the introduction of “as soon as practicable” and “no more than 24 hours” add a loophole to our CA law that is NOT supported by federal requirements.
Steven Lane
02:36:41
“It would likely be considered an interference for purposes of information blocking if a health care provider established an organizational policy that, for example, imposed delays on the release of lab results for any period of time in order to allow an ordering clinician to review the results or in order to personally inform the patient of the results before a patient can electronically access such results (see also 85 FR 25842 specifying that such a practice does not qualify for the “Preventing Harm” Exception).To further illustrate, it also would likely be considered an interference:where a delay in providing access, exchange, or use occurs after a patient logs in to a patient portal to access EHI that a health care provider has (including, for example, lab results) and such EHI is not available—for any period of time—through the portal.where a delay occurs in providing a patient’s EHI via an API to an app that the patient has authorized to receive their EHI.”
Steven Lane
02:39:59
Technology restrictions = “infeasibility”
Steven Lane
02:40:09
Operational delays = information blocking
Steven Lane
02:40:26
Or may
Rim Cothren, CDII CalHHS
02:42:21
I believe that the CMS rule or FAQs may call out timing of ADT notification timelines we can reference.
Steven Lane
02:45:38
👍🏼
John Helvey
02:47:30
Early Exchange - as long as you clarify what you just stated in this policy it will help eliminate confusion
Steven Lane
02:48:28
Good question, Deven.